28 / 374
SOCT User Manual Version 10.0 rev. A
Safety standards
CAUTION: Before the first use, the device operator should be trained how to use
the system efficiently and safely.
NOTE: SOCT system can be connected only to power supply socket equipped with
properly connected grounding pin.
The SOCT system complies with all requirements of the directive 93/42/EEC (MDD - Medical
Devices Directive).
The SOCT is type B applied parts (chin rest support and forehead support) and class I protection
against electric shock.
Usually SOCT is a part of larger Medical System, which consists of many other medical and
non-medical devices. Medical system in general and all its components have to fulfill the
requirements of IEC 60601-1 standard.
In order to comply with the IEC 60601-1 standard all non-medical devices must be connected
to the Isolating Transformer. By connecting the devices to the Isolating Transformer, the
leakage current is reduced to the level which is in line with the IEC standard.
The Isolating Transformer fulfills requirements of IEC 60601-1 standard for medical electrical
system.
The Isolating Transformer supplies the power for non-medical devices connected to electric
not grounded mains in a room.
The Isolating Transformer can be installed in patient environment in accordance with IEC
60601-1 standard.
OPTOPOL recommends connecting the system via an uninterruptible power supply (UPS) to
the wall outlet.
NOTE: Only the PC, monitor and printer have to be connected to the isolating
Transformer. Connecting non-medical devices in other way than presented in
chapter 3.3 Safety standards can lead to electric shock or damage of the devices.
NOTE: It is strictly forbidden to connect any non-medical or medical devices which
are not included within the SOCT system to the Isolating Transformer e.g. lamp,
vacuum cleaner, etc.
NOTE: The SOCT must not be connected to the Isolating Transformer, but directly
to the main power supply socket or to the dedicated supply socket in the dedicated
table.
To Next Page
Loading...
